Cleared Traditional

K831799 - PLASTIC DISPOSABLE RAZOR

K831799 · I M, Inc. · General & Plastic Surgery device
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Jul 1983
Decision
45d
Days
-
Risk

K831799 is an FDA 510(k) clearance for the PLASTIC DISPOSABLE RAZOR.

Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I M, Inc. devices

Submission Details

510(k) Number K831799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date July 18, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 16
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K831799.
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POSTURE MIRROR
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FOAM WEDGE
K812482 · Maddak, Inc. · Sep 1981
NU-BORN BABY BATH KIT
K802366 · American Hospital Supply Corp. · Oct 1980